MiniSim driving simulator results “reassure” FDA in data review
MiniSim driving simulator results “reassure” FDA in data review leading to approval of Sprout’s ADDYI® (flibanserin).
St Petersburg, FL (August 19, 2015): Cognitive Research Corporation announced that MiniSim driving simulator results were described as “reassuring” in the FDA briefing book provided to the FDA Advisory Committee that recommended approval of Sprout’s ADDYI® (flibanserin), which received FDA approval on August 18, 2015.
Sprout Pharmaceuticals, Inc., had been notified by the FDA that a dedicated driving study was required pre-approval for their drug being developed for treatment of hypoactive sexual desire disorder in premenopausal women. Specifically, the agency requested a driving study be conducted to “assess next-day impairment,” before resubmitting the compound to the Agency for approval. Sprout Pharmaceuticals selected Cognitive Research Corporation to design, implement, analyze and report on the results of the driving study.
The findings of the driving study were provided to the FDA for review. The FDA reviewers described the driving study results as “… reassuring with regard to patients who take flibanserin…” The favorable driving study results were presented to the FDA Advisory Committee on June 4, 2015. The committee recommended approval of Sprout’s ADDYI® (flibanserin) for treatment of hypoactive sexual desire disorder in premenopausal women.
Cognitive Research Corporation will demo the state-of-the-art PC-based driving simulator, the CRCDS MiniSim used in the Sprout study at CNS Summit 2015, October 8-11, 2015 in Boca Raton, Florida.
About Cognitive Research Corporation:
Cognitive Research Corporation(CRC) is the exclusive provider of the state-of-the-art PC-based driving simulator, MiniSim, developed by the University of Iowa’s National Advanced Driving Simulator. The CRCDS-MiniSim has been fully validated for use in clinical trials. The simulator has proven sensitivity to CNS sedatives, stimulants, alcohol, and to medical conditions such as obstructive sleep apnea. CRC has a fleet of identical driving simulators capable of conducting single or multi-site registration trials in the U.S., Canada, and in Europe.
Gary G. Kay, Ph.D., President of Cognitive Research Corporation, is a leading expert in assessment of driving impairment and in assessment of cognitive functioning. He was co-author of the National Highway Traffic Safety Administration drug impaired driving protocol which was cited by the Draft FDA Guidance.
The FDA Draft Guidance, released in January 2015 specifies the conditions under which a dedicated driving study is required. Previously, driving studies were only being required for sedative hypnotics. The draft guidance applies to drugs which are intended for chronic (including chronic-intermittent) outpatient use by adults who drive. The guidance indicates that a dedicated driving study will be needed when “accumulating data suggest a potential for driving impairment.” The guidance specifies that driving simulators are suitable for conducting these studies.
Click here for the FDA’s briefing document, reviewing the driving study.
About the CNS Summit:
Founded by drug developers, the core principles of Collaboration, Innovation, and Technology drive the CNS Summit’s programs and initiatives to shape the future of drug development. The CNS Summit is differentiated by its programming and is known for its innovative content and format, as well as the strong emphasis on collaboration between different stakeholders to solve pressing challenges in drug development. CNS Summit 2015 will take place from October 8-11, 2015 in Boca Raton, Florida.
For information about driving simulation services and MiniSim technology, contact Bobbie Theodore, Alliance Director, Bobbie@AllianceSites.com